The impact of a barrier enclosure on time to tracheal intubation: a randomized controlled trial.

PURPOSE: Novel devices such as the barrier enclosure were developed in hopes of improving provider safety by limiting SARS-CoV-2 transmission during tracheal intubation. Nevertheless, concerns arose regarding a lack of rigorous efficacy and safety data for these devices. We conducted a randomized controlled trial to evaluate the impact of the barrier enclosure on time to tracheal intubation. METHOD: After Research Ethics Board approval, elective surgical patients with normal airway predictors were randomly allocated 1:1 to tracheal intubation with or without a barrier enclosure. The primary outcome was time to tracheal intubation. Secondary outcomes included first-pass success rate, total time of airway manipulation, anesthesiologists' perception of intubation difficulty, likelihood of use in SARS-CoV-2-positive patients, and patients' perception of comfort and acceptability. RESULTS: There were 48 participants in the barrier enclosure group and 46 participants in the control group. The mean (standard deviation [SD]) time to tracheal intubation was 62 (29) sec with barrier closure and 53 (27) sec without barrier enclosure (mean difference, 9 sec; 95% confidence interval, - 3 to 20; P = 0.14). Anesthesiologists rated the difficulty of intubation higher with barrier enclosure (mean [SD] visual analogue scale score, 27 [26] mm vs 9 [17] mm; P < 0.001). There were no significant differences in other secondary outcomes. CONCLUSION: In healthy surgical patients with normal airway predictors, the use of a barrier enclosure during tracheal intubation did not significantly prolong time to intubation or decrease first-pass intubation success. Nevertheless, there was an increase in difficulty of intubation perceived by the anesthesiologists with use of a barrier enclosure. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT04366141); registered 28 April 2020.

RéSUMé: OBJECTIF: De nouveaux dispositifs tels que des boîtes de protection ont été mis au point dans l'espoir d'améliorer la sécurité des fournisseurs de soins en limitant la transmission du SRAS-CoV-2 pendant l'intubation endotrachéale. Néanmoins, des inquiétudes ont été soulevées au sujet d'un manque de données rigoureuses sur l'efficacité et l'innocuité de ces dispositifs. Nous avons réalisé une étude randomisée contrôlée afin d'évaluer l'impact d'une boîte de protection sur le temps de l'intubation endotrachéale. MéTHODE: Après avoir reçu l'approbation du Comité d'éthique de la recherche, des patients de chirurgie élective présentant des prédicteurs des voies aériennes normales ont été aléatoirement répartis à un ratio de 1:1 pour une intubation endotrachéale avec ou sans boîte de protection. Le critère d'évaluation principal était le temps nécessaire à l'intubation endotrachéale. Les critères d'évaluation secondaires comprenaient le taux de réussite à la première tentative, le temps total de manipulation des voies aériennes, la perception par les anesthésiologistes de la difficulté d'intubation, la probabilité d'utilisation chez les patients atteints du SRAS-CoV-2, et la perception de confort et d'acceptabilité des patients. RéSULTATS: Il y avait 48 participants dans le groupe avec boîte et 46 participants dans le groupe témoin. Le temps moyen (écart type [ÉT]) pour l'intubation endotrachéale était de 62 (29) sec avec la boîte et de 53 (27) sec sans la boîte (différence moyenne, 9 sec; intervalle de confiance de 95 %, − 3 à 20; P = 0,14). Les anesthésiologistes ont estimé que la difficulté d'intubation était plus élevée avec une boîte de protection (score moyen sur l'échelle visuelle analogique [ÉT], 27 [26] mm vs 9 [17] mm; P < 0,001). Il n'y avait pas de différences pour les autres critères d'évaluation secondaires. CONCLUSION: Chez les patients chirurgicaux en bonne santé avec des prédicteurs de voies aériennes normales, l'utilisation d'une boîte de protection pendant l'intubation endotrachéale n'a pas prolongé de manière significative le temps d'intubation ni réduit le taux de réussite de l'intubation à la première tentative. Néanmoins, il y avait une augmentation de la difficulté d'intubation perçue par les anesthésiologistes avec l'utilisation d'une boîte de protection. ENREGISTREMENT DE L'éTUDE: www.clinicaltrials.gov (NCT04366141); enregistrée le 28 avril 2020.

Time to adapt in the pandemic era: a prospective randomized non -inferiority study comparing time to intubate with and without the barrier box.

BACKGROUND: The challenges posed by the spread of COVID-19 disease through aerosols have compelled anesthesiologists to modify their airway management practices. Devices such as barrier boxes are being considered as potential adjuncts to full PPE's to limit the aerosol spread. Usage of the barrier box raises concerns of delay in time to intubate (TTI). We designed our study to determine if using a barrier box with glidescope delays TTI within acceptable parameters to make relevant clinical conclusions. METHODS: Seventy-eight patients were enrolled in this prospective non-inferiority controlled trial and were randomly allocated to either group C (without the barrier box) or the study group BB (using barrier box). The primary measured endpoint is time to intubate (TTI), which is defined as time taken from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end-tidal CO 2. 15 s was used as non-inferiority margin for the purpose of the study. We used an unpaired two-sample single-sided t-test to test our non- inferiority hypothesis (H 0: Mean TTI diff ≥15 s, H A: Mean TTI diff < 15 s). Secondary endpoints include the number of attempts at intubation, lowest oxygen saturation during induction, and the need for bag-mask ventilation. RESULTS: Mean TTI in group C was 42 s (CI 19.2 to 64.8) vs. 52.1 s (CI 26.1 to 78) in group BB. The difference in mean TTI was 10.1 s (CI -∞ to 14.9). We rejected the null hypothesis and concluded with 95% confidence that the difference of the mean TTI between the groups is less than < 15 s (95% CI -∞ to 14.9,p = 0.0461). Our induction times were comparable (67.7 vs. 65.9 s).100% of our patients were intubated on the first attempt in both groups. None of our patients needed rescue breaths. CONCLUSIONS: We conclude that in patients with normal airway exam, scheduled for elective surgeries, our barrier box did not cause any clinically significant delay in TTI when airway manipulation is performed by well-trained providers. The study was retrospectively registered at clinicaltrials.gov (NCT04411056) on May 27, 2020.